Apparatus and method for positive closure of an internal tissue membrane opening

ABSTRACT

The invention provides a device having two components: a needle advancing apparatus slidable longitudinally along a catheter to advance needles into a tissue membrane, such as a blood vessel wall, around an opening in the membrane; and, a suture retrieval assembly insertable through the catheter beyond a distal side of the tissue membrane. The needle advancing apparatus advances suture through the tissue wall. The suture retrieval assembly grabs the suture on the distal side of the tissue membrane for extraction thereof through the opening in the tissue membrane. A method for suturing a membrane beneath the patient&#39;s skin is also disclosed.

This application is a continuation of application Ser. No. 07/963,053,filed Oct. 19, 1992, now U.S. Pat. No. 5,304,184.

BACKGROUND OF THE INVENTION

The present invention relates generally to an apparatus and method forclosure, such as by suturing, of tissue membrane openings. The presentinvention has particular application in the closure of openings in bloodvessel walls after catheterization procedures in the cardiovascularsystem have been performed.

A wide variety of techniques have been employed to provide nonsurgical,less invasive procedures in a medical patient. These includelaparoscopy, arthroscopy, and various other techniques in which surgicaland/or medicational procedures are performed via tubes, such ascatheters, rather than full-scale "cut down" surgery. One such techniqueis the Seldinger technique involving the placement of guide wires andcatheters in the cardiovascular system of the patient. Although suchnonsurgical procedures typically greatly enhance the recovery time ofthe patient when compared to more conventional cut down surgery,nevertheless, openings formed in tissue membranes, such as arterialwalls, take time to heal.

Prior methods and devices typically involve placement of collagenexternal to the puncture wound with or without the placement of apolylactide member internal to the puncture wound such as in the lumenof the blood vessel. Potential problems with this approach involve theincrease in thrombosis that has been observed to follow placement of apermanent intravascular device, the known effects of collagen toactivate platelets and consequently induce thrombosis, and theoccurrence of a systemic autoimmune inflammatory response followingimplants of bulk collagen.

By way of background, other suturing and stitching devices and methodsare disclosed in the following U.S. Pat. Nos.: 5,037,433 to Wilk et al.,4,957,498 to Caspari et al., 4,836,205 to Barrett, 4,437,465 to Nomotoet al., and 4,898,155 to Ovil et al.

The present invention provides a suture-based method of closure whichcircumvents the need for placement of any large piece, such as a stent,within the blood vessel, avoiding attendant risks of thrombosis.Additionally, use of collagens can be avoided, reducing the risk ofthrombosis or of an inflammatory autoimmune reaction. The presentinvention provides these advantages while being usable in the context ofnoninvasive techniques, such as laparoscopy, cardiovascular procedures,or other procedures avoiding conventional cut down surgery, therebyproviding the benefits without the necessity for direct visualization ofthe opening in the tissue which is to be closed. Additionally, thepresent invention provides substantially reduced healing times formedical patients, reducing patient discomfort and risk and also reducinghospital and personnel costs associated with prolonged healing.

SUMMARY OF THE INVENTION

According to one embodiment, the present invention provides anonsurgical method for closure of an opening in a tissue membranebeneath the skin of a patient. The method includes the steps ofproviding a tubular member having a lumen therein beneath the skin ofthe patient and in close proximity to and preferably protruding throughthe opening; inserting a retrieval assembly through the lumen and pastthe opening to a location on a distal side of the tissue membrane;advancing needle means for passing sutures through the tissue membraneat separate suture locations around the opening; grabbing the sutureswith the retrieval assembly on the distal side of the tissue membrane;retrieving the sutures through the opening by withdrawing the retrievalassembly out through the opening; and, drawing together the suturelocation with the sutures.

According to another embodiment, the present invention provides anapparatus for passing sutures through a tissue membrane located beneaththe skin of a patient around an opening in the tissue membrane. Theapparatus includes a tubular body having a side wall defining a lumentherein. The tubular body allows introduction of material into thepatient through the lumen beyond the tissue membrane. The apparatusfurther includes an array of at least two needles disposed around thetubular body which carry a respective length of suture. The array ofneedles is advanceable through the tissue to a distal side thereof toprovide sutures at separate suture locations in the tissue membranearound the opening.

According to another embodiment, the present invention provides anapparatus for retrieving sutures, alone or in combination with thepreviously described apparatus, comprising a retrieval assembly havingan elongated portion having a first end. The first end includes at leastone flexible bow having a distal end, a proximal end, and a centralportion therebetween. The apparatus further includes a tension memberattached to the distal end of the bow member. The tension member and theproximal end of the bow are selectively movable with respect to eachother to urge the distal end and the proximal end towards each other andapart from each other, causing the central portion of the bow to deflectoutwardly away from the tension member to receive sutures, and todeflect inwardly toward the tension member in a collapsed position tosecure sutures at the first end. The first end in the collapsed positionis sized to be withdrawn through a catheter lumen.

One object of the present invention is to provide an improved apparatusand method for positive closure of a subcutaneous tissue membraneopening.

Another object of the present invention is to provide closure of tissuemembrane openings, such as punctures in blood vessels.

Another object of the present invention is to reduce the need for theuse of collagens and/or intravascular devices, such as stents, forclosure of puncture wounds.

A further object of the present invention is to reduce the clotting timeand the healing time required for a puncture wound in a tissue membrane.

These and other objects and advantages of the present invention will beapparent from the written description and drawing figures herein.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1-13 sequentially illustrate one embodiment of the methodaccording to the present invention to place sutures in a tissuemembrane.

FIGS. 14a-14f sequentially illustrate one embodiment of the methodaccording to the present invention to span sutures across an opening ina tissue membrane.

FIG. 15a illustrates a partially cutaway side view of one embodiment ofa needle advancing apparatus according to the present invention.

FIG. 15b illustrates a side view of one needle of the apparatus of FIG.15a shown in isolation.

FIG. 15c is a cross-section looking in a distal direction as if takenalong lines 15c--15c of FIGS. 15a and 16 collectively.

FIG. 15d is a partial cross-sectional view of an alternative embodimentof a tubular member of assembly 51 within the sheath of apparatus 50.

FIG. 16a illustrates a partially cutaway side view of one embodiment ofa suture retrieval assembly according to the present invention.

FIG. 16b is a partially cut away side view of another embodiment of asuture retrieval assembly according to the present invention.

FIG. 16c is a rear view of the proximal end of the assembly of FIG. 16b.

FIG. 17a illustrates the present invention with the needle sheathretracted, the needles in a deployed mode, and the distal end of theretrieval assembly in an expanded mode.

FIG. 17b is a rear cutaway view of the suture magazine 60 of FIG. 17ashowing the needle crank portions in phantom lines.

FIG. 17c illustrates the present invention with the needle sheathadvanced, the needles in a compact mode, and the distal end of theretrieval assembly in a contracted mode.

FIG. 17d is a rear cutaway view of the suture magazine 60 of FIG. 17cshowing the needle crank portion in phantom lines.

FIGS. 18-22 illustrate alternative embodiments of the distal end of theretrieval assembly.

DESCRIPTION OF THE PREFERRED EMBODIMENT

For the purposes of promoting an understanding of the principles of theinvention, reference will now be made to the embodiment illustrated inthe drawings and specific language will be used to describe the same. Itwill nevertheless be understood that no limitation of the scope of theinvention is thereby intended, such alterations and furthermodifications in the illustrated device and method, and such furtherapplications of the principles of the invention as illustrated thereinbeing contemplated as would normally occur to one skilled in the art towhich the invention relates.

The present invention provides for the closure of openings in tissuemembranes beneath the skin of a medical patient. The invention isuseful, for example, to close the opening in the wall of a blood vesselcaused by catheterization procedures. The invention is advantageous inthat it allows closure of such openings without the need to surgicallycut open the patient to visualize the closure procedure. In addition toclosure of openings in blood vessels, the invention is useful forclosing a variety of openings in various tissue membranes beneath theskin of a patient. Regarding the terminology herein, "distal" meanstoward the patient and away from the operator (doctor), and conversely"proximal" means toward the operator and away from the patient.

The general procedure of the invention begins with the placement of acatheter through the opening in the tissue membrane. A retrieval deviceis inserted through the catheter and beyond the opening to the distalside of the membrane. The distal end of the retrieval device is expandedand pulled tightly against the inside surface of the tissue membrane.Thereafter, one or more needles carrying sutures are inserted throughthe tissue membrane around the opening. The retrieval device grabs thesutures on the distal side of the membrane. The retrieval device is thencontracted and removed through the catheter, pulling the sutures withit. Thereafter, knots are formed in the sutures to draw the openingclosed for healing. The preferred embodiment of the present inventionhas two primary components, retrieval assembly 51 (see FIG. 16) andneedle advancing apparatus 50 (see FIG. 15a). Collectively, these formthe suturing device 52.

Referring to FIGS. 1-13 and FIGS. 14a-14f, a representative illustrationof the present inventive method is illustrated for positive closure ofopening 99 in tissue membrane 43 of blood vessel 42. The blood vessel islocated beneath the skin 40 of a medical patient, and is accessedthrough opening 41 in the skin. Note that the side wall of blood vessel42 is illustrated partially cut away to facilitate illustration of themethod, it being understood that ordinarily the method is performed onlywith opening 99 in tissue membrane 43. Tissue membrane 43 has a proximalside or surface 44 on the outside thereof and an opposite distal side orsurface 45 on the inside thereof as illustrated. While the presentinvention is illustrated for repairing blood vessel 42, it is to beunderstood that the present invention may have applicability in positiveclosure of openings in other tissue membranes in a medical patient whichare located beneath the surface of the skin. Such openings may includeopenings caused by medical procedures, such as laparoscopy, angiography,and others, as well as openings caused by traumatic wounds, includingpuncture wounds.

FIG. 1 illustrates blood vessel 42 having a sheath 56, such as acatheter, passing through opening 41 and opening 99 and into theinterior lumen of the blood vessel, beyond distal side 45. Sheath 56includes a side wall defining one or more lumens therein as is wellknown. Sheath 56 typically may be initially placed in blood vessel 42 tofacilitate introduction of material into the blood vessel, such as guidewires, catheters, scopes, dilators, inflatable balloons, or any othermedical appliance, as well as introduction and/or removal of fluids suchas blood, medication, and/or contrast media. In one application, thepresent inventive method is typically employed after such techniquesand/or procedures, referred to herein generally as catheterizationprocedures, are completed and such medical devices have been removedfrom sheath 56.

Needle advancing apparatus 50 is illustrated in FIG. 1 disposed aroundthe outside of the side wall of sheath 56, and slideable longitudinallyalong the length thereof. Apparatus 50 is described in greater detailbelow. Apparatus 50 includes a tubular member 62 having a side walldefining a lumen therein with an array of needles disposed around sheath56 protected by a needle guard 55. The needles each have respectivelengths of sutures attached thereto.

The distal end 53 of retrieval assembly 51 is inserted (FIG. 2) into theproximal end of the lumen of sheath 56. Retrieval device 51 is fullyinserted into sheath 56 (FIG. 3) to position the distal end 53 beyondthe distal end of sheath 56 and on the distal side of the membrane 43.The distal end of the retrieval assembly is initially in a collapsedstate, being sized with a cross-sectional dimension to allow insertionand withdrawal of distal end 53 through the lumen of sheath 56.

Distal end 53 is then expanded within blood vessel 42 (FIG. 4) on thedistal side of membrane 43. The expanded state in this embodiment isformed by a plurality of bows, such as bow member 54, which are bulgedoutwardly. In this particular embodiment the configuration is analogousto an expandable bolt used to anchor fixtures to a building wall. Themechanics of this expansion are described more fully below, butgenerally are caused by manipulating two handle members at the proximalend of retrieval assembly 51, namely by rotational release ofspring-loaded and/or screw threaded handles, such as movement of handle75 with respect to handle 73 as shown by the arrow. The distal endpreferably includes an expandable outer member and an inner member whichrotates within the outer member.

Distal end 53 is expanded and urged against the distal side 45 of thetissue membrane (FIG. 5). Such urging is preferably accomplished bypulling on handle 73, which is connected to distal end 53, in thedirection of the arrow. By urging the distal end against the distal sideof the tissue (e.g., against the inside of the blood vessel) the bloodvessel is distended somewhat and held relatively stationary tofacilitate insertion of the suture carrying needles through the tissuemembrane. A hemostasis seal member, such as boot 631 (see FIGS. 4 and 5)described further below, seals opening 99 against outflow of fluid suchas blood during the procedure.

Needle advancing apparatus 50 is advanced forwardly along sheath 56towards opening 99. It is slid far enough forward (i.e., distally) sothat needle guard 55 passes through opening 41 in the skin, with thedistal edge of the needle guard near opening 99 in the blood vessel (seeFIG. 6). In this position, the needle guard is poised to be withdrawn,exposing the needles in close proximity to opening 99.

The needle guard 55 is then withdrawn (FIG. 7) by sliding it along tubemember 62 (which surrounds sheath 56) to expose the suturing needles,such as needle 57. In the illustrated embodiment, apparatus 50 includesfour such needles arrayed equidistantly around sheath 56 for insertioninto the tissue membrane around opening 99. The needles are initially ina compact mode. The needles, such as needle 57, are then moved radiallyoutwardly (FIG. 8) (not to scale) away from their relatively radiallycompact position illustrated in FIG. 7. The manner of deployment in thepreferred embodiment is described further below, but generally is causedby ninety degree rotation of a suture magazine 60 with respect totubular member 62 as shown by the arrow. The needles are arranged as acranking mechanism which, in response to rotation of magazine 60, causesthe needles to move radially outward. In this way, the needles arebetter radially spaced to allow insertion in the tissue membrane aroundthe circumference of opening 99. It is to be understood that this crankmechanism is only one approach, and other approaches of radiallydeploying the needles may be utilized, such as spring biased needleswhich spring outwardly.

The needles, such as needle 57, are then advanced through the tissuemembrane (see FIG. 9). This is caused by forward (i.e. distal) movementof apparatus 50 along sheath 56. The needles are advanced through thetissue membrane at various suture locations caused by the puncturingaction of the needles. The needles carry suture or other suitablesurgical closure materials. In the preferred embodiment, each needle isa solid stylet with an eyelet near its distal tip carrying adoubled-back length of suture 58 (see FIG. 15b). Accordingly, fourlengths of suture, each doubled back, are simultaneously advancedthrough the tissue membrane from proximal side 43 to distal side 45. Thesutures carried by the needles are preferably stored in four independentmagazine compartments within suture magazine 60. Not only is the sutureadvanced beyond distal wall 45 of the blood vessel, but furthermore, theneedles and their respective sutures are inserted interstitially betweenthe suture grabbing elements of distal end 53 of the retrieval device51.

Handle member 73 is attached to the proximal end of retrieval assembly51 and is rotated with respect to handle 71. This causes rotation ofdistal end 53 as shown by the arrows (FIG. 10). This rotating, in thepreferred embodiment, grabs the sutures carried by the needles. Thisgrabbing action along with the rotation may cause a suture to be pulledout of the magazine compartments (shown partially cutaway) in magazinechamber 60 as it is being drawn into the distal end of the retrievalassembly. A variety of mechanisms, rotational and nonrotational, may beused for this grabbing feature, it being understood that the embodimentillustrated and the embodiments described later are merely exemplary. Itshould be further noted that the grabbing action occurs beyond openingand occurs on the distal side 45 of the blood vessel wall.

Distal end 53 of the retrieval assembly is then collapsed to allowwithdrawal through the lumen of sheath 56 (see FIG. 11). Such collapsingmay be accomplished by a variety of mechanisms. In the preferredembodiment this is done by longitudinal movement of handle 75 towardshandle 73 as illustrated by the arrow in FIG. 11, collapsing the bows ofdistal end 53 into a cross-sectionally compact mode. In this mode, thesutures remain held by distal end 53.

FIG. 12 illustrates retrieval assembly 51 completely withdrawn fromapparatus 50. Such withdrawal is accomplished by pulling the retrievalassembly, including elongated tube member 63 and distal end 53, out ofthe lumen of sheath 56. Since the sutures, such as suture 58, are stillconnected to distal end 53, the withdrawal pulls the sutures out ofmagazine 60 distally through the suture locations in thetissue-membrane. The sutures are thereby doubled back and pulledoutwardly through the lumen of sheath 56.

Apparatus 50 is thereafter withdrawn from opening 99 and opening 41 inthe patient, carrying the sutures outwardly through opening 41. FIG. 13illustrates needle guard 55 advanced forwardly, covering the tips of theneedles. Such movement of needle guard 55 forwardly is done prior towithdrawal of apparatus 50 and after the needles are retracted into aradially compact mode in a manner inverse to the steps described inconnection with FIGS. 6 and 7. Thereafter, apparatus 50 is removedentirely with the sutures being separated (by cutting or otherwise) sothat what remains are four lengths of suture (each doubled back)threaded through a respective four suture locations around opening 99 inthe blood vessel.

The foregoing method has been described with the simultaneous advancingof four needles and sutures through the tissue membrane. However, it isto be understood that the present procedure may be done with more orless needles and sutures and/or be done with sequential advancing ofneedles and suture through the tissue membrane. The foregoing method isadvantageous in that it may be performed "blind" inside of a patientbeneath the surface of the skin of the patient, without the necessityfor endoscopic or other viewing. The present invention may also beperformed with the assistance of endoscopic equipment in appropriatecircumstances. However, such threading operation through opening 41 inthe skin without a full cut-down opening of the skin to access and viewthe opening in the blood vessel or other membrane is extremelyadvantageous and does not require endoscopic viewing.

FIGS. 14a through 14f illustrate one example of a technique to positionthe sutures as illustrated in FIG. 13 across opening 99 to positivelydraw the opening closed for healing. In FIGS. 14a-14f, only two (ratherthan four) sutures are illustrated for purposes of drawing clarity andsimplicity, it being understood that the same technique may be repeatedfor the other sutures. FIG. 14a illustrates suture 58a and suture 58bwhich are typical surgical sutures (sterilized) which will eventuallydissolve in the patient after the wound is healed. Suture 58a is doubledback to form loop 59a at one end with free ends 61a and 62a at theopposite end. Suture 58a is threaded downwardly through suture location157a from the proximal side of the tissue membrane to the distal side ofthe tissue membrane, and is doubled back out through opening 99 in bloodvessel 42. Similarly, suture 58b is doubled back, forming loop 59b andfree ends 61b and 62b. Suture 58b is threaded through suture location157b.

Free end 61a is pulled through (see the bold arrow in FIG. 14b) suturelocation 157a and outwardly through openings 99 and 41 so that thesuture is no longer doubled back. Then, distal end 61a is insertedthrough (see the bold arrow in FIG. 14c) loop 59b of the opposite suture58b. Pulling (see the bold arrows) on both of free ends 61b and 62b(FIG. 14d) causes loop 59b to be drawn downwardly, pulling suture 58adownwardly with it. Continued pulling on free ends 61b and 62b pullsloop 59b upwardly through suture location 157b (FIG. 14e), pullingsuture 58a upwardly through suture location 157b.

FIG. 14f illustrates suture 58a passing through the tissue membrane atsuture locations 157a and 157b, spanning diametrically across opening99. Thereafter, suture 58a is drawn tight, such as by advancing or by"throwing" a suturing knot (e.g. an overhand knot) across opening 99,and positively drawing it closed. Such knot techniques and knot throwingmay be accomplished with the aid of a pusher to advance the suturingknot downwardly towards opening 99. It is to be understood that theforegoing threading illustrated in FIGS. 14a-14b is merely exemplary,and other techniques may be used, including techniques to provide asuture circumferentially around opening 99 in a purse stringconfiguration. After opening 99 is drawn closed, opening 41 is closed inthe conventional manner and the patient is allowed to heal.

FIGS. 15a-17d illustrate in greater detail the needle advancingapparatus 50 and the retrieval assembly 51 previously described, Sheath56 forms a central core of apparatus 50. Sheath 56 comprises a side walldefining a central lumen 56a passing all the way through assembly 50.Although as illustrated sheath 56 has a single lumen, it is contemplatedthat the present invention may be utilized with a multi-lumen sheathand/or device having endoscopic capabilities. Sheath 56 has housing 56dforming a chamber therein mounted at its proximal end. Housing 56d has aseal 56b mounted therein. This seal may be a variety of designs, butpreferably is an elastomeric gasket body, such as silicone rubber,having slits and/or other openings therein to allow selective insertionand removal of medical instruments, such as guide wires, catheters andother such devices, while maintaining a fluid tight seal therearound. Inthis way, blood or other bodily fluid is prevented from leaking out, andunwanted air is prevented from entering into the body.

Housing 56d further has a side port (optional) 56e which ordinarily willhave a stop-cock or other closure mechanism (not shown). In this way,catheter 56 may act as a hemostasis cannula to remain indwelling in theblood vessel 42 throughout the prior medical procedure.

Apparatus 50 further includes a tubular member 62 surrounding sheath 56and providing a housing for holding the four needles, such as needle 57.Needle 57 is shown in isolation in FIG. 15b and includes needle tip 57aat its distal end, a proximal portion 57b, and a central portion 57ctherebetween. Central portion 57c defines a longitudinal axis ofrotation. Proximal portion 57b is connected to the central portion bycrank portion 57e. Similarly, the needle tip is eccentric to the axisdefined by central portion 57c since it is connected to the centralportion by crank portion 57d. As illustrated in FIG. 15a, needle 57 ismounted with the central portion 57c rotationally movable within tubularmember 62, and with proximal portion 57b mounted in thread magazine 60.Thread magazine 60 is rotationally movable over a ninety degree arc withrespect to tubular member 62, and such movement causes a cranking actionof needle 57 ranging from fully compact to fully deployed, optionallywith locks in each position. Such cranking action causes rotation of thecentral portion 57c which, in turn, causes cranking or swinging of crankportion 57d and needle tip 57a inwardly and outwardly with respect tosheath 56. In this way, with needle guard 55 withdrawn as illustrated inFIG. 15a, needle tip 57a, along with the needle tips of the other threeneedles, is cranked to swing radially inwardly and outwardly withrespect to sheath 56 to allow positioning of the needles for insertionthrough the tissue membrane around the hole. Such cranking action isillustrated comparatively between FIG. 17a and FIG. 17c, and betweenFIGS. 17b and 17d. FIG. 15c illustrates a cross sectional view, lookingdistally, through apparatus 50 and assembly 51 with the needles in acompact mode.

Suture 58 is housed in suture chamber 65 within suture magazine 60. InFIG. 15a, the remaining suture magazines are shown empty forillustration purposes, it being understood that in operation eachcarries suture for its respective needle. Suture chamber 65 includes apair of suture openings 66 through which the suture is pulled as thesuture is advanced through the tissue membrane of the patient. Thesuture passes between sheath 56 and tubular member 62 and is candiedthrough an eyelet at the tip of its respective needle. Alternativeneedle constructions may also be used, such as a hollow needle cannulacarrying suture downwardly through the center of the cannula and doubledback on the outside of the cannula away from the cutting edge.

The needle assembly and member 62, along with the needle magazine 60,may be modified to allow placement around sheath 56 even after sheath 56is in place in the patient, as an option to the illustrated version inwhich tubular member 62 is positioned around sheath 56 prior toinsertion of sheath 56. For example, member 62 may be longitudinallysplit and provided as two mating parts, such as a clam shell, around theoutside of sheath 56 (not shown). FIG. 16a illustrates a partiallycutaway side view of retrieval assembly 51. Retrieval assembly 51 has ahandle assembly on the proximal side thereof opposite of distal member53, with elongated tubular member 63 therebetween. Elongated tubularmember 63 may comprise a catheter having a wire or other tension member80 disposed in its central lumen. Distal end 53 has a plurality of innerbows and outer bows such as bow 54. These bows are formed in oneembodiment by slits in the wall of tubular member 63a (outer bow) andslits in the wall of tubular member 63b (inner bows). Each bow has adistal end 53d, a proximal end 53p, and a central portion 53ctherebetween. Tension member 80 is attached to the distal end 53d byconnection 80a. As illustrated, each inner bow may have serrations alongits inside edge. When tension member 80 is pulled towards the proximalend of assembly 51, it draws the distal ends of the bows toward theproximal ends of the bows, causing the central portions to bulgeoutwardly in a radial direction. Such bulging is illustrated bycomparing FIG. 17c (end 53 in a contracted position) with FIG. 17a (end53 in an expanded position). In the expanded position, serrations on theinner bows are exposed to help grab the sutures.

Movement of tension member 80 with respect to elongated tubular body 63may be accomplished in a variety of ways, one of which is illustrated inFIG. 16a. Specifically, handle 75 is moved longitudinally with respectto handle 71 and handle 73 to cause such relative movement. Handle 75 ismounted and slidable longitudinally within handle 73. Handle 75 is urgedaxially away from handle 73 by compression spring 77. Handle 75 isconnected to tension member 80, whereas handle 73 is connected toelongated member 63b. Pin 76a secured to handle 75 is slidable withinz-shaped slot 76b in handle 73. In this way, relative movement betweenthe handles is at a predetermined and controlled distance with apositive locking feature. Furthermore, handle 73 is rotatable withinhandle 71. Specifically, handle 73 includes a circumferential groove 72bwhich rides around radially inward detent 72a, allowing radial rotationbut not allowing axial movement between handles 73 and 71. Such rotationis further controlled and limited by pin 74a abutting stop member 74b.The rotational position of distal end 53 is thereby limited and isindexed at a known position. By maintaining handle 71 stationary theouter bows of tubular member 63a (affixed thereto) are maintainedstationary; whereas rotation of handle 73 within handle 71 cause theinner bows of tubular member 63b to rotate inside of the stationary,outer bows. The rotating inner bows have serrations which grab thesuture while the outer bows remain stationary to shield surroundingtissue from abrasion or other damage.

Through visual indexing markings, or actual physical forced alignment,the relative axial position between the bows of distal end 53 ofretrieval assembly 51 may be predetermined with respect to the needles57 of assembly 50. As a result, when the needles are advanced throughthe tissue membrane, the operator may ensure that the bows are placed toallow interstitial insertion of the needles between the outer bows. Itis contemplated that this indexing mechanism may be facilitated byproviding apparatus 50 in a sterilized kit with retrieval assembly 51.For example, tubular member 63 and sheath may be modified as illustratedin FIG. 15d with tubular member 763 having a longitudinal outer rib 763Rwhich slides in a corresponding longitudinal inner groove in sheath 756.A mating interaction may be provided between retrieval assembly 51 andapparatus 50, such as by mating interaction between the distal end ofhandle 71 and housing 56d to maintain alignment of the needles and thebows.

FIGS. 16b and 16c illustrate an alternative embodiment of the retrievalassembly of the present invention. The structure noted by referencecharacters are similar to those used in connection with FIG. 16a exceptthat a "1" or "2" is set forth in the hundredths digit of thecorresponding reference character. For example, the handle 175 as inFIG. 16b and 16c is analogous to handle 75 in FIG. 16a. The retrievalassembly has three key components, handle 171, handle 173 and handle175. Handle 171 is affixed to tubular member 63a; handle 173 is affixedto tubular member 263b; and, handle 175 is affixed to tension member 80.

Handle 175 moves rearwardly (proximally) with respect to handle 171,thereby causing tension member 80 to be pulled in tension rearwardly(proximally) with respect to tubular member 63a. Such rearward movementis actuated by withdrawing pin 276a from recess 276b, such as byradially inward movement of the lever to which pin 276a is attached.Such withdrawal of the pin from the recess causes handle 175 to moverearwardly due to the forces acted upon by it by compression spring177b. Pin 176a of handle 175 rides in longitudinal slot 176b of handle171 to maintain alignment and to restrict relative travel distance.Tension is thereby exerted on tension member 80, causing the distal endof the retrieval assembly to expand as described in connection with FIG.16a. Movement of handle 175 forward causes the distal end to collapse toallow passage through sheath 56.

Handle 173 is first advanced and then rotated. Handle 173 islongitudinally movable with respect to handle 171, thereby causinglongitudinal movement of tubular member 263b with respect to tubularmember 63a. Handle 173 may be advanced forwardly (distally) with pin172a tiding in longitudinal slot 172c overcoming the bias of compressionspring 177a causing extension of tubular member 263b. Handle 173 isrotatable with respect to handle 171, causing tubular member 263b torotate with respect to tubular member 63a. Rotation occurs with pin 172ariding in circumferential groove 172b. Rotation of handle 173 and theresulting rotation of tubular member 263b causes rotation of thesnagging mechanism within the bows of the distal end of the retrievalassembly. Longitudinal withdrawal of tubular member 263b causeswithdrawal of the snagging mechanism at the distal end of the assembly,such as described further in connection with FIGS. 19 and 20 below.

FIGS. 17a-17d provide schematic comparisons of the moving parts of thepresent invention in different positions. For example, FIG. 17a and FIG.17b show needle guard 55 retracted or withdrawn, with needles 57 in aradially expanded mode and with distal end 53 of the retrieval assemblylike wise in an expanded mode. Needle guard 55 includes handle 55aattached thereto to facilitate manual sliding along the outside oftubular member 62. Conversely, FIG. 17c and FIG. 17d illustrate needleguard 55 advanced in a sheathed position with the needles 57 in aradially retracted position and with a distal end 53 of the retrievalassembly likewise in a contracted position. Comparison between FIGS. 17band 17d illustrates the cranking action of cranking portion 57e of theneedles. Note further that these two figures illustrate sutures in dualcoils in all four chambers of the suture magazine.

FIG. 18 shows distal end 153 with outer bow 153a and inner serrated bow154. Serrated bow 154 is formed from slits in flexible tubular member63b having at least one serrated edge along each bow, as illustrated.Serrated bow 154 deflects outwardly similarly to the action of bow 153awhen tension member 80 is pulled proximally with respect to elongatedmember 63a. In such expanded state, end 153 comprises four inner bowswithin four outer bows. The inner bows rotate as previously describedwith respect to the stationary outer bows. A sealing member, such aselastomeric boot 631, preferably is provided at the proximal base of theouter bows. This seal 631 functions to seal the opening which is beingclosed during the procedure so fluid, such as blood, is prevented fromflowing out. Seal 631 expands as the bows are expanded sufficiently toseal the opening.

Referring to FIG. 19, an alternative embodiment of the distal end of theretrieval device is shown as distal end 253, with one of the bowspartially cutaway for drawing clarity. The bows, such as 253a, areformed from slits in elongated tube 63a which surrounds tension member80. Bow 253a includes distal end 253d, proximal end 253p and centralportion 253c. Two serrated members, such as serrated member 254, arerigidly attached to a collar 263b, which is an end of tubular member263b described in connection with FIG. 16b above, and which is mountedover tension member 80. Rotation of the collar/tubular member 263b andserrated member 254 within fixed distal end 253 causes snagging andgrabbing of sutures which are attached to the needles (previouslydescribed) positioned interstitially between the bows. Seal 631 isprovided and functions as described above. Pulling on tension member 80and its end piece 80a cause the bows to expand. Collar 263b may be aportion of an elongated tube which is axially movable to retractserrated members 254 within the outer bows as described with FIG. 16b.

As a further alternative, FIG. 20 illustrates distal end 353 with bow353a surrounding prong 354. As illustrated, other prongs (shown inphantom lines) are mounted over tension member 80 to grab and snagsuture. Note that optionally, instead of a boot 631 providing a seal,the bow configuration is altered to provide a frustoconical sealingsurface around the base of the outer bows. As with the device of FIG.19, tubular member 263b may be rotated and retracted to withdraw prongs354 into a collapsed state.

FIG. 21 illustrates yet another embodiment, in which distal end 453includes a plurality of bows, such as bow 453a, formed in an outersheath 63a. Sheath 63a is mounted around elongated member 463a which inturn is mounted around tension member 80. Inside the outer bows is asecond set of bows, such as bow 454. These inner bows 454 may be of ahook fabric material, such as Velcro® material. Such hook material maybe used in connection with multi-filament and/or monofilament suturematerial which acts as nap material to snag on the hook material of bow454 as bows 454 are rotated within the outer bows. A seal may optionallybe added.

As stated, other approaches to grasping the suture material on thedistal side of the membrane to be closed may be provided. FIG. 22illustrates distal end 553 with a membrane 554 of an elastomericmaterial, such as latex rubber, stretched around the outside of theexpandable bows of member 63a and/or as part of a balloon. It has beenfound that when the interstitial needles penetrate through such latexrubber with the suture, the suture remains in place in the latex, evenupon removal of the needles. A rotational inner member is typically notrequired, although optionally may be provided. Membrane 554 also acts asa hemostasis seal.

While the invention has been illustrated and described in detail in thedrawings and foregoing description, the same is to be considered asillustrative and not restrictive in character, it being understood thatonly the preferred embodiment has been shown and described and that allchanges and modifications that come within the spirit of the inventionare desired to be protected.

What is claimed is:
 1. A method for closure of an opening in a tissue membrane located beneath the skin of a patient, the tissue membrane having a distal side and a proximal side, comprising the steps of:providing a member for delivery of a retrieval assembly in proximity to the opening in the tissue membrane; inserting a first, distal end of a retrieval assembly beneath the skin of the patient and through the opening in the tissue membrane to a location on the distal side of the tissue membrane; providing at least one needle having a needle tip for penetrating through the tissue membrane and for carrying at least two lengths of suture material through the tissue membrane; advancing said needle through the tissue membrane adjacent but spaced from the opening at at least two separate suture locations, wherein suture material is advanced through the tissue membrane at the suture locations; grabbing the suture material with said retrieval assembly; retrieving said suture material through the opening by withdrawing the distal end of said retrieval assembly out through the opening; and drawing the suture locations together with said suture material passing through the suture locations.
 2. The method of claim 1 and further comprising the step of:expanding the distal end of said retrieval assembly on the distal side of the tissue membrane after said inserting step.
 3. The method of claim 2 and further comprising the step of:urging the expanded distal end of said retrieval assembly toward the opening and into contact with the tissue membrane prior to said step of advancing the needle.
 4. The method of claim 1 further comprising the steps of:removing a shield from over the needle tip to expose the needle tip; and moving the needle from a compact mode to a deployed mode prior to said step of advancing the needle.
 5. The method of claim 4 and further comprising the steps of:withdrawing the needle from the tissue membrane; moving the needle back to the compact mode; shielding the tip of the needle; and, withdrawing the needle from the patient, wherein said withdrawing step occurs prior to said step of drawing together said suture locations.
 6. The method of claim 1 wherein the tissue membrane is a blood vessel and wherein the opening is an opening formed by catheterization of the blood vessel, and wherein said step of inserting a distal end of the retrieval assembly occurs after a cardiovascular catheterization procedure.
 7. An apparatus for suturing a tissue membrane located beneath the skin of a patient, the tissue membrane having a distal side and a proximal side, the sutures extending through the membrane at locations positioned adjacent to and around an opening in the tissue membrane, comprising:a tubular body having a portion thereof extendable through the opening and beyond the distal side of the tissue membrane; at least two needles disposed around said tubular body, said needles carrying a respective length of suture, said needles being advanceable through the tissue membrane to provide suture material at separate suture locations in the tissue membrane adjacent to the opening; and a retrieval assembly having an elongated portion disposable within said tubular body and with a first distal end disposable through the opening in the tissue membrane, the first end being adapted to grab suture material at a location on the distal side of the tissue membrane.
 8. The apparatus of claim 7 and further comprising a needle shield received about said tubular body allowing selective shielding and exposing of said needles, said tubular body being advanceable with said shield in a first position shielding said needles, said shield being selectively movable to a second position to expose said needles adjacent to the opening in the tissue membrane.
 9. The apparatus of claim 8 wherein said needles are movable from a compact mode to a deployed mode radially away from said tubular member, said needles in said compact mode being shieldable by said needle shield, said needles in said deployed mode having needle tips exposed.
 10. The apparatus of claim 9 wherein each of said needles has a distal end including a respective needle tip, a proximal end, and a central portion therebetween, wherein the central portion of each of said needles defines a respective longitudinal pivot axis, the distal end and the proximal end of said needles each being eccentric to the respective longitudinal pivot axis, and wherein rotational movement of the proximal end of each of said needles causes a respective central portion to move to cause the respective distal end of each of said needles to move between the compact mode and the deployed mode.
 11. An apparatus for suturing, comprising:a retrieval assembly having .an elongated portion with a distal end; wherein said distal end is selectively expandable and collapsible and wherein said distal end in a collapsed position is insertable through a catheter lumen; said distal end being expandible along a distal side of a tissue membrane to be sutured while said elongated portion is disposed in said catheter lumen, said distal end being expandible to receive suture advanced through said tissue membrane with said distal end in an expanded position, wherein said distal end further includes at least one needle tarrying suture and, an elastomeric membrane expandable on the distal side of an opening in a tissue membrane, wherein said elastomeric membrane receives said needle carrying suture pierced therethrough, and wherein upon withdrawal of the needle from the elastomeric membrane the suture remains pierced through said elastomeric membrane for withdrawal of the elastomeric membrane and suture together through the opening in the tissue membrane.
 12. An apparatus for suturing, comprising:a retrieval assembly having an elongated portion with a distal end; wherein said distal end is selectively expandable and collapsible and wherein said distal end in a collapsed is insertable through a catheter lumen; said distal end being expandible along a distal side of a tissue membrane to be sutured while said elongated portion is disposed in said catheter lumen, said distal end being expandible to receive suture advanced through said tissue membrane with said distal end in an expanded position; a tubular catheter having a portion thereof extendable through an opening in and beyond a distal side of the tissue membrane; and at least two needles disposed around said tubular body, said needles carrying a respective length of suture, said needles being advanceable through the tissue membrane to provide suture material at separate suture locations in the tissue membrane adjacent to the opening.
 13. The apparatus of claim 12 wherein the distal end includes expanding elements and wherein said needles are disposed to insert sutures interstitially between said expanding elements. 